TRIAPIN Prolonged release tablet Ref.[108212] Active ingredients: Felodipine Ramipril Ramipril and Felodipine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Triapin 2.5mg/2.5mg prolonged release tablet.

Pharmaceutical Form

Triapin 2.5mg/2.5mg tablets are circular (diameter approx 9 mm), apricot coloured, biconvex and engraved H/OD on one side and marked 2.5 on the other side.

Qualitative and quantitative composition

Each tablet contains 2.5 mg of felodipine and 2.5 mg of ramipril.

Excipient(s) with known effect:

Each tablet contains 52 mg lactose anhydrous. Each tablet contains 2.50 mg macrogolglycerol hydroxystearate (polyoxyl hydrogenated castor oil).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Felodipine

Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance. Felodipine is effective in all grades of hypertension.

Ramipril

Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.

Ramipril and Felodipine

Both the calcium antagonist felodipine and the ACE inhibitor ramipril reduce blood pressure by dilation of the peripheral blood vessels. Calcium antagonists dilate the arterial beds while ACE inhibitors dilate both arterial and venous beds. Vasodilatation and thereby reduction of blood pressure may lead to activation of the sympathetic nervous system and the renin-angiotensin system. Inhibition of ACE results in decreased plasma angiotensin II.

List of Excipients

Cellulose microcrystalline
Hyprolose
Hypromellose
Iron oxides E172
Lactose anhydrous
Macrogol 6000
Macrogolglycerol hydroxystearate
Maize starch
Paraffin
Propyl gallate
Sodium aluminium silicate
Sodium stearyl fumarate
Titanium dioxide E171

Pack sizes and marketing

PVC/PVDC blisters: 10, 14, 15, 21, 28, 30, 50, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/082/001

Date of first authorisation: 13 July 1998
Date of lastest renewal: 19 September 2007

Drugs

Drug Countries
TRIAPIN Germany, Spain, Croatia, Ireland, United Kingdom

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